So-Called “Clinical Equipoise” and the Argument from Design

Abstract

In this article, I review and expand upon arguments showing that Freedman's so-called “clinical equipoise” criterion cannot serve as an appropriate guide and justification for the moral legitimacy of carrying out randomized clinical trials. At the same time, I try to explain why this approach has been given so much credence despite compelling arguments against it, including the fact that Freedman's original discussion framed the issues in a misleading way, making certain things invisible: Clinical equipoise is conflated with community equipoise, and several versions of each are also conflated. But a misleading impression is given that, rather than distinct criteria being arbitrarily conflated, a puzzle is solved and a number of features unified. Various issues are pushed under the rug, hiding flaws of the “clinical equipoise” approach and thus deceiving us into thinking that we have a solution when we do not. Particularly significant is the ignoring of the crucial distinction between the individual patient decision and the policy decision.

Keywords:

• clinical equipoise
• community equipoise
• individual equipoise
• randomized clinical trial
• theoretical equipoise

Notes

1. The term “indifferent” that Veatch (2002) uses is in fact better than “uncertain” in a couple of important ways — it better fits with the idea that the assessments require value judgments as well, and it doesn't so easily suggest a continuum, as in the example where one retains some uncertainty even once statistical significance has been reached. Unfortunately, its use in a phrase like “the indifference of the clinical community” might leave an unintended impression.